ABSTRACT
The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.
Subject(s)
China , Drugs, Chinese Herbal , Information Storage and Retrieval , Medicine, Chinese Traditional , Nonprescription Drugs , Quality ControlABSTRACT
As a part of evidence-based medical practice to obtain high-level evidence through summarizing previous studies,systematic review and meta-analysis have been paid more and more attention.The number of papers published is increasing recently.However,many relevant published papers in biomedical sciences revealed low quality,such as non-uniform and incomprehensive items,and even unclear narrative in many portions of review.These problems reduced the evidence-based role of systematic review and Meta-analysis paper,and affected the interpretation and effective availability of summarized evidence.Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) is a report standard,but it has not been well-known in ophthalmology of China.The systematic review and meta-analysis published by Chinese ophthalmologists are less guided by PRISMA.Learning PRISMA is helpful not only for improving quality of papers,but also for acquainting the key elements of high-level clinical research,even for standardizing the medical code of conduct,which are important to make it better for conduct evidence-based research in ophthalmology.